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Comparing two methods for treating wide-neck abdominal aortic aneurysms

Randomized Controlled Clinical Trial on the Application of Heli-FX EndoAnchors in Conjunction With the Endurant II/IIs Endograft in Infrarenal Aortic Aneurysms With a Wide Infrarenal Neck (HERCULES Trial)

NA · Rijnstate Hospital · NCT05484115

This study is testing whether a new way to repair wide-neck abdominal aortic aneurysms works better than the standard method for patients with this condition.

Quick facts

PhaseNA
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorRijnstate Hospital (other)
Locations36 sites (Washington, Arkansas and 35 other locations)
Trial IDNCT05484115 on ClinicalTrials.gov

What this trial studies

The HERCULES trial is a randomized controlled clinical trial that aims to compare the clinical outcomes of endosuture aneurysm repair (ESAR) using the Heli-FX EndoAnchor system against standard endovascular aneurysm repair (EVAR) with the Endurant II/IIs stent graft system. This multicenter trial will recruit up to 300 subjects across 40 sites in Europe and the US, focusing on patients with infrarenal abdominal aortic aneurysms that have wide proximal neck diameters. Participants will be followed for up to five years to assess the effectiveness and safety of both treatment methods. The study is designed to fill the gap in clinical evidence regarding these two approaches in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older with infrarenal aortic aneurysms and proximal neck diameters between 28 mm and 32 mm.

Not a fit: Patients with anatomical features outside the guidelines for the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide more effective treatment options for patients with wide-neck abdominal aortic aneurysms, potentially improving their outcomes.

How similar studies have performed: While both treatment methods are commercially approved, this study is novel as it specifically compares their effectiveness in patients with wide proximal neck diameters, an area where clinical evidence is currently lacking.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age 18 years or older
* Provided written informed consent
* Clinical necessity for treatment of the AAA, according to the current guidelines in the geographies participating
* Elective repair
* Eligible anatomy for treatment with the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system according to the IFU of both devices
* Infrarenal neck diameter ≥ 28 mm and ≤32 mm
* Proximal neck length ≥10mm

Exclusion Criteria:

* Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system
* Planned use of AUI main body device
* Patient is participating in another clinical study, potentially conflicting with the outcomes of the current study.
* Patient with eGFR \< 30 ml/min/1.73m2 before the intervention
* Patient's life expectancy \<2 years as judged by the investigator
* Patient has a psychiatric or other condition that may interfere with the study
* Patient has a known allergy to any device component
* Patients with a systemic infection who may be at increased risk of endovascular graft infection.
* Patient has a coagulopathy or uncontrolled bleeding disorder
* Patient has a ruptured, leaking, or mycotic aneurysm
* Patient is not eligible for standard EVAR
* Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months
* Patient is pregnant (Female patients of childbearing potential only)
* Patient has active COVID-19 infection or has been diagnosed with long COVID-19 requiring hospitalization within the 6 months prior to procedure.
* Patient has previously been treated with stent grafts in the aorto-iliac arteries

Where this trial is running

Washington, Arkansas and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aortic Aneurysm, Abdominal, AAA, Endovascular treatment, Wide proximal neck, EndoAnchors, Infrarenal, EVAR, ESAR

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.